Aseptic Fill/Finish and Lyophilization

Therapure BioPharma is a therapeutic protein-specialized Contract Development and Manufacturing Organization (CDMO) that offers a range of biomanufacturing services including technology transfer & process development, analytical development & testing, scale-up & cGMP manufacturing, aseptic fill/finish, lyophilization and support services.

Therapure is the only Canadian company that offers aseptic fill/finish of glass vials, preformed IV infusion bags and pre-filled syringes at both clinical and commercial scale. Therapure has significant experience, capabilities and capacity for the fill/finish and lyophilization of therapeutic proteins. Within their 130,000 ft2 cGMP facility Therapure has Health Canada- licensed aseptic fill/finish suites for glass vials and validated fill/finish suites

for IV infusion bags and pre-filled syringes.

A Mutual Recognition Agreement (MRA) between Health Canada and the EU allows for selected aseptic fill/finished glass vials produced at Therapure to be sold directly into Europe without receiving county pre-inspections. This shortens time to market and allows for lower inventory requirements for Therapure’s European clients.

Therapure offers fill/finish services for their client’s bulk drug substance either produced off-site or as an add-on to Therapure’s own cGMP manufacturing services. Therapure is an ideal partner for biotech companies as they can provide this integrated service from manufacturing to fill/finish to storage and distribution of finished product. Therapure provides lyophilization cycle development and optimization services and in 2010 added commercial lyophilization capacity to its clinical scale lyophilization capabilities allowing production batches in the tens of thousands.

Capacities and Volumes :-

Therapure Biopharma, a proteins development company inspects 100% of the drug product containers prior to final labelling and packaging so as to meet their rigorous quality control standards. Therapure provides warehousing and material handling in their cGMP compliant warehouse for finished goods with next day delivery to clinical and commercial sites throughout North America and Europe.

Container Type Filling Capacity / Hour

Container Volumes (mL)

Vial Filling 3,000 X 2 mL vials 2 - 200Preformed IV Bag Filling

800 bags 50 – 500

Prefilled Syringe 1,200 x 2mL syringes

0.5 - 20

Scale Chamber Size # Shelves Temp Range

Batch to Vial Size Range

Clinical Lyophilization

1.1 m2

(12 ft2)6 Shelves(114mm)

-70 to +650C

4,400 Units x 2mL

2,000 Units x 10mL

Therapure’s customer focused flexibility, scientific expertise and scalable capacity allows Therapure to adapt to meet the fill/finish and lyophilization needs of its clients at every stage of the development and commercialization process.

By Therapure:- Aseptic Fill/Finish and Lyophilization